Model of Vaginal Laxity (MVL)
Construction of Diagnostic Model for Vaginal Laxity
This study is a multicenter, prospective cohort study. The main purpose of the study is to construct diagnostic model for vaginal laxity.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
The main purpose of the study is to construct diagnostic model for vaginal laxity based on multimodal clinical data. Besides, for the enrolled patients, we conducted follow-up for those whose vaginas could accommodate more than two fingers. According to the treatment methods they received, they were divided into three groups: Patients in Group 1 underwent pelvic floor muscle exercises, those in Group 2 received physical therapy, and those in Group 3 underwent surgical treatment. This grouping is based on clinical routine diagnosis and treatment opinions. It only observes the improvement effect of vaginal relaxation in patients of different groups and does not conduct any additional interventions on the patients. Therefore, this study is an observational study.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Xiuli Sun
- Telefonní číslo: +86 13834964768
- E-mail: sunxiuli@pkuph.edu.cn
Studijní místa
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Beijing, Čína, 100044
- Sun
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Kontakt:
- Xiuli Sun
- Telefonní číslo: +86 13834964768
- E-mail: sunxiuli@pkuph.edu.cn
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Kontakt:
- E-mail: sunxiuli@pkuph.edu.cn
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Chengdu, Čína
- Han
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Kontakt:
- Han
- Telefonní číslo: 028-60660000
- E-mail: hxtfyyhfb@163.com
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Kunming, Čína
- Han
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Kontakt:
- Han
- Telefonní číslo: 650224
- E-mail: 2616300020@pku.edu.cn
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Lanzhou, Čína
- Pu
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Kontakt:
- Pu
- Telefonní číslo: 0931-5188888
- E-mail: 749979857@qq.com
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Kontakt:
- E-mail: 749979857@qq.com
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Nanchang, Čína
- Wang
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Kontakt:
- Wang
- Telefonní číslo: 0791-86224432
- E-mail: jxfbjfb@163.com
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Shenzhen, Čína
- Hu
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Kontakt:
- Hu
- Telefonní číslo: 0755-83923333
- E-mail: bdszyy@pkuszh.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Female patients who visited the gynecology outpatient department of the participating project hospital from September 2026 to September 2027.
Popis
Inclusion Criteria:
- Women over the age of 18 who have sex
- Understand and voluntarily sign the written informed consent form.
Exclusion Criteria:
- Gynecological examination confirmed the presence of stage III or above pelvic organ prolapse
- There is cognitive impairment, unable to understand the content of the questionnaire or cooperate to complete the transvaginal ultrasound examination
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Group 1: Pelvic floor muscle training
For patients whose vaginas can accommodate more than two fingers, if they undergo pelvic floor muscle exercises, they will be assigned to Group 1. |
pelvic floor muscle training |
|
Group 2: physical therapy
For patients whose vaginas can accommodate more than two fingers, if they receive physical therapy, including laser, radiofrequency, and biofeedback, they will be classified into Group 2. |
laser treatment |
|
Group 3: Surgery
For patients whose vaginas can accommodate more than two fingers, if they receive surgeries, they will be classified into Group 3. |
surgery |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Construction of diagnostic model for vaginal laxity
Časové okno: From enrollment to the end of treatment at 12 months
|
Integrating multi-model indicators to construct gold standard diagnostic model for vaginal laxity, including age (year), weight (kg), height (m), gravidity, parity, vaginal tactile imaging, pelvic floor ultrasound, POP-Q points, modified oxford muscle strength, female sex function index (FSFI), International Consultation on Incontinence Questionnaire (ICIQ), Pelvic Floor Distress Inventory-20(PFDI-20) and Overactive bladder symptom score (OABSS) |
From enrollment to the end of treatment at 12 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Severity of overactive bladder
Časové okno: From enrollment to the end of treatment at 12 months
|
Overactive bladder symptom score (OABSS) questionnaire will be used to assess the severity of overactive bladder |
From enrollment to the end of treatment at 12 months
|
|
Sex function
Časové okno: From enrollment to the end of treatment at 12 months
|
Female sex function index (FSFI) questionnaire will be used to assess sex function |
From enrollment to the end of treatment at 12 months
|
|
Severity of pelvic floor dysfunction
Časové okno: From enrollment to the end of treatment at 12 months
|
Pelvic Floor Distress Inventory-20 (PFDI-20) questionnaire will be used to assess severity of pelvic floor dysfunction |
From enrollment to the end of treatment at 12 months
|
|
Severity of lower urinary tract symptom
Časové okno: From enrollment to the end of treatment at 12 months
|
International Consultation on Incontinence Questionnaire (ICIQ) will be used to assess severity of lower urinary tract symptom |
From enrollment to the end of treatment at 12 months
|
|
Subjective degree of vaginal laxity
Časové okno: From enrollment to the end of treatment at 12 months
|
The vaginal laxity questionnaire (VLQ) will be used to assess subjective degree of vaginal laxity |
From enrollment to the end of treatment at 12 months
|
|
Sexual satisfaction
Časové okno: From enrollment to the end of treatment at 12 months
|
The sexual satisfaction questionnaire (SSQ) will be used to assess sexual satisfaction |
From enrollment to the end of treatment at 12 months
|
|
Patients' satisfaction for the treatment
Časové okno: From enrollment to the end of treatment at 12 months
|
Patient Global Impression of Improvement (PGI-I) will be used to assess patients' satisfaction for the treatment. |
From enrollment to the end of treatment at 12 months
|
|
Severity of pain
Časové okno: From enrollment to the end of treatment at 12 months
|
Visual Analogue Scale (VAS) will be used to assess the severity of pain |
From enrollment to the end of treatment at 12 months
|
|
Urodynamic test
Časové okno: From enrollment to the end of treatment at 12 months
|
Urodynamic tests were performed for free uroflowmetry, post-void residual urine volume, and cystometry in the sitting position. In free uroflowmetry, the maximum flow rate (Qmax), average flow rate (Qave), and flow time were recorded, while bladder volumes were measured during the filling cystometry test at the patient's first sense, first desire, and strong desire for urination. Besides, we paid attention to whether detrusor overactivity (DO) was noted during filling cystometry. The detrusor pressure at maximum flow (PdetQmax) and the maximum urethral closure pressure (MUCP) were also measured |
From enrollment to the end of treatment at 12 months
|
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Pelvic floor ultrasound
Časové okno: From enrollment to the end of treatment at 12 months
|
Bladder neck position, uterine descent, bladder neck descent, cervical position, retrovesical angle, rectal ampulla descent, bladder neck opening, urethral rotation angle, levator hiatus area, anorectal angle (ARA), puborectalis muscle integrity, perineal body thickness, perineal body length will be recorded. |
From enrollment to the end of treatment at 12 months
|
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Vaginal tactile imaging
Časové okno: From enrollment to the end of treatment at 12 months
|
The images from the vaginal tactile imaging will be collected. |
From enrollment to the end of treatment at 12 months
|
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Maximum vaginal capacity index
Časové okno: From enrollment to the end of treatment at 12 months
|
From enrollment to the end of treatment at 12 months
|
|
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Modified oxford muscle strength
Časové okno: From enrollment to the end of treatment at 12 months
|
From enrollment to the end of treatment at 12 months
|
|
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Pelvic organ prolapse quantification (POP-Q)
Časové okno: From enrollment to the end of treatment at 12 months
|
From enrollment to the end of treatment at 12 months
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Safety of surgery
Časové okno: From enrollment to the end of treatment at 12 months
|
The following relevant data will be collected: the duration of the surgery, the amount of bleeding, the changes in hemoglobin levels before and after the surgery, the length of hospital stay, whether there was any intraoperative organ damage, and postoperative urinary retention. |
From enrollment to the end of treatment at 12 months
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- PKUPH-VL
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